Changes in HCV therapy - approval of Sofosbuvir
Friday, 30 January 2015 13:55
Dr Stephen Ryder, BSG Vice-President Hepatology & Dr Andrew Austin, Chair BSG Liver Section
There are two major changes in HCV therapy which now have NICE and/or NHSE approval for use. The first is that commissioning guidance for the use of Simiprevir is published (http://www.england.nhs.uk/commissioning/spec-services/npc-crg/group-a/a02/). This allows G1 patients without Q80K to access triple therapy now using Simiprevir instead of Boceprevir or Telaprevir.
The second and probably more significant development is the approval of Sofosbuvir. The approval can be summarised as below:
Sofosbuvir in combination with pegylated interferon + ribavirin (Peg-IFN+RBV)
|HCV genotype||Adult patient population|
|Genotype 3||Treatment-naïve with cirrhosisa|
|Genotype 4, 5, or 6||Treatment-naïve & experienced with cirrhosisa|
Sofosbuvir in combination with RBV
|HCV genotype||Adult patient population|
|Genotype 3||Treatment-naïve with cirrhosisb|
|Treatment-experienced with cirrhosisb|
The NHSE approval is for cirrhotic patients to access treatment in April with non-cirrhotic patients from July.
There is a meeting at Barts on 3rd March 2015 (advertised by BVHG) to establish clinical guidelines as to who to treat with what when. It is highly likely that by July other agents approvals will make the interferon component of the regimen outdated. NHSE will establish a process by which the drugs will be distributed shortly but it would seem prudent for centres to enter local negotiations now in order all are ready to prescribe when we are given the approvals. It is pretty certain that similar data gathering will be required as for EAP.
Liver Section News Update Winter 2014
Wednesday, 07 January 2015 10:02
Stephen D Ryder, BSG Vice-president, Hepatology
There are a number of themes to the development of hepatology. The future of specialised commissioning and what that may mean for liver services, the recently released Lancet Commission into liver disease, new drugs for hepatitis C and how they may be managed probably being the most pressing. I apologise if the following has a very English rather than UK flavour but the devolved nations, particularly Scotland, are well ahead of England in their strategic approach to liver disease and most of the new structures and changes are England specific. I will attempt, in future, to give some feedback on how things may work in Wales and Northern Ireland.
The Hepatobiliary Clinical Reference Group (CRG), which advises NHS England on specialised services, met again in October. There has been a 3 month "pause" to most workstreams in NHS England while Simon Stevens assessed the future strategy of the NHS. The exception to this pause was the hepatitis C programme which continued recognising the magnitude of new developments and the implication for patients.
The Early Access Programme to Sofosbuvir (with either Daclatasvir or Ledipasvir) continues and represents a strong commitment from NHS England to fund HCV therapy for those in greatest need (in this case patients with decompensated cirrhosis). There are now 550 patients who have started therapy across the Country and the outcomes will be monitored through HCV UK where almost all patients are registered.
The early access programme (EAP) set the framework for how high cost drugs may be allocated by NHS England in future with a bidding process for coordinating centres working with networks of clinicians delivering care locally. At the present time it is not clear how NHSE will deal with Sofosbuvir post NICE (the review should be finalised this month) and it seems clear that existing mechanisms for drug application, which vary markedly across England, will need to continue in 2015/16 as there is little time now for a bidding process similar to the EAP to be staged. We continue to await NHSE guidance on Simeprevir, the Scottish as usual are ahead in approving this with a "cost per cure" approach. We do not yet know what NHSE wish to do although replacing Telaprevir/Boceprevir with Simeprevir seems a sensible and relatively low cost option which may take some of the pressure off the Sofosbuvir debate.
The EAP has been regarded as a significant success by NHSE and the principles of networked arrangements really should guide us in how liver services in areas other than HCV should develop.
The NHS Forward View (in my view one of the most sensible documents to emerge from NHSE in the post-Lansley era) details new models for how care could be provided in future (www.england.nhs.uk/ourwork/futurenhs/). These include:
- allowing GP practices to join forces into single organisations that provide a broader range of services including those traditionally provided in hospital;
- creating new organisations that provide both GP and hospital services together with mental health, community and social care;
- helping patients needing urgent care to get the right care, at the right times, in the right place, by creating urgent care networks that work seven days a week;
- sustaining local hospitals where this is the best solution clinically and is affordable and has the support of local commissioners;
- concentrating services into specialist centres where there is a strong relationship between numbers of patients and the quality of care.
The BSG will need to respond to this in how it frames its plans but it does seem to fit well with hepatology and emphasises the networked principles and moving care out of hospital that we know have to happen if we are to turn round the epidemic of cirrhosis.
The Lancet Commission on liver disease was launched on 26th November and provides a template for changes we need to make for service delivery. The report will help in producing a series of workstreams which will try to address specific areas from primary care education through to liver transplant services. The BSG will be a key partner in taking these programmes forward.
Public Health England have a very functional infrastructure and have identified their priorities regionally. This is likely to be another very powerful lever for change if you are in an area where liver disease is a priority. PHE have published data on prevalence of liver disease nationally (http://fingertips.phe.org.uk/profile/) which is vital reading for your local authority areas. I do not know nationally how this has translated into local priorities for PHE and as yet how many areas have liver disease as a key part of Joint Strategic Needs Assessments, this is a key step for ensuring that the whole community is linked together and has a common aim. This will be the focus of a future update.
Alcohol Treatment Matrix
Thursday, 03 April 2014 09:11
An innovative way of presenting evidence on alcohol treatment has been praised by several BSG members - the 'Go to Matrix' which presents a lot of clinical information in a clear way:
The Alcohol Treatment Matrix is concerned with the treatment of alcohol-related problems among adults (another deals with drug-related problems). It maps the treatment universe and for each sub-territory (a cell) lists the most important UK-relevant research and guidance. Across the top, columns move from specific interventions through how their impacts are affected by the widening contexts of practitioners, management, the organisation, and whole local area treatment systems. Down the rows are the major intervention types implemented at these levels. Inside each cell is our pick of the most important documents relevant to the impact of that intervention type at that contextual level. Visit the matrices page for articles, presentations, and a video explaining their genesis and construction.
Public Health Research project 09/3001/09 report published:
Wednesday, 06 November 2013 10:01
"Reducing alcohol-related harm in disadvantaged men: development and feasibility assessment of a brief intervention delivered by mobile telephone, Public Health Research".
MRC Public Health Intervention Development Scheme (PHIND)
Wednesday, 06 November 2013 09:57
The Public Health Intervention Development scheme (PHIND) is a new MRC funding scheme designed specifically to provide support for early phase development of public health interventions. This rapid response funding scheme is aimed at improving the initial evidence on which the development and evaluation of public health interventions are based. Studies should address an important UK or global public health issue and offer an innovative approach to intervention development or applying an existing intervention in a new setting.
The scheme's remit ranges from primary research developing and designing the intervention to feasibility studies, encompassing:
- developing theory
- modelling process and outcomes
- assessing feasibility
Systematic reviews, meta analyses and pilot studies are outside the remit of the PHIND scheme. Applicants can apply for up to £150K for a maximum of 18 months and the scheme will operate three times a year. For further information, please see the MRC website.
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