5.1 Section 7(6) of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires clinical commissioning groups, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this appraisal within 3 months of its date of publication. However, in this appraisal, following a request made by NHS England and a consultation with stakeholders, the period during which NHS England has to comply with the recommendations has been extended to 31 July 2015.
5.2 NHS England set out 4 principal reasons why it considered a variation to the deferred funding period is justified:
The need to complete the work of the 'task and finish' service redesign group.
A substantial demand for treatment with sofosbuvir, which it anticipates will increase further, because patients who have not sought active treatment in the past will come forward, and which will be increased further by new patients identified through public awareness campaigns and screening of high‑risk groups, which have either been initiated or which are planned.
The need to establish a hepatitis C network, which will involve setting up a series of centres with the staff and the other resources and systems necessary to provide a multidisciplinary team approach to care.
The establishment of a national database and dashboard to monitor and support individual care.
5.3 NHS England is clearly concerned about its ability to make sofosbuvir available in the way it considers necessary for planned, efficient and properly audited care. It advised NICE that it would be better able to do so if an extension to the deferred funding period to the end of July 2015 were to be made available.
5.4 The argument for an extension, based on the need to establish a national database and dashboard was not supported by a timescale from NHS England. In addition, it appears that the dashboard component is, in any event, already being put in place. The consequences of not having the database at the same time as the dashboard were not made clear.
5.5 The work of the task and finish group is likely to be completed within the normal deferred funding period.
5.6 The question as to whether an extension to the deferred funding period is warranted appears to turn on whether either, or a combination of a substantial volume of patients seeking access to sofosbuvir, and the need to establish the hepatitis C network (with or without the database and monitoring function) amount to a substantive argument. Patients who consider that they can benefit from treatment now, supported as they may well be by their clinicians, may not wish to wait for treatment even though they may recognise the benefits of their care being part of a nationally‑networked service. NHS England, on the other hand, argues that it has a responsibility to manage its resources efficiently in the interests of both current and future patients.
5.7 It is clear that sofosbuvir marks a step change in the treatment available to patients with hepatitis C. NICE has recommended its use, with some restrictions because it is clinically and cost effective. Having done so, the Institute should be cautious about introducing any delay in patients gaining access to treatments from which they may benefit. However, it should also avoid placing the NHS in a position of confronting a significant tide of expectation from patients for access to care which they do not feel equipped to provide. To do so would risk sub‑optimal treatment decisions and may subject the current service provision to undue stress.
5.8 The responsibility for securing care for the NHS in England rests with NHS England. NICE should be cautious and sure of its judgement before requiring NHS England to provide services that it does not consider that it can provide, or provide safely and efficiently. In effect, NICE would have to conclude that NHS England was mistaken. NHS England has indicated that it does not yet have in place the arrangements that it considers necessary for sofosbuvir to be provided, to the full extent recommended in this guidance. Its position, in setting out what it believes it needs to do to put the necessary arrangements in place, has credibility. NICE needs to be wary of substituting its judgement for NHS England's in this respect.
5.9 In its response to consultation on the proposal to extend the deferred funding period, NHS England reiterated the need for clinical networks to support the use of new interventions for the treatment of chronic hepatitis C, which would allow the best quality of clinical care, and allow the most clinically and cost effective prescribing of high cost drug treatments. It further suggested that the network model will ensure better equity of access, noting that many patients with chronic hepatitis C infection come from marginalised groups who do not engage well with health services, and that there is a risk that without proper structures in place a significant proportion of patients in need will not get access to care. It argues that there is a substantial group of patients (mainly but not exclusively those with cirrhosis) who run the risk of serious harm if treatment is delayed, and that it will 'fast track' for consideration, by April 2015, an interim policy to provide oral antiviral therapy to all patients with cirrhosis (plus a small number with severe non‑hepatic complications of HCV).
5.10 The consultation proposal was supported by the Department of Health on the condition that arrangements are put in place to provide access to treatment for the most seriously ill patients.
5.11 NICE heard from patient and professional groups that all the centres likely to be using these drugs have been treating patients with pegylated interferon in combination with ribavirin, boceprevir, and telaprevir for some considerable time, and that they already have staff trained and experienced in the use and monitoring of interferon and ribavirin. These consultees further stated that both simeprevir and sofosbuvir have very few significant side effects or drug‑drug interactions (certainly fewer than the first generation protease inhibitors), and many of the centres will already be using sofosbuvir under NHS England's early access programme. NICE was advised that multidisciplinary team approaches to approving treatment are already in place in most treatment providers, as a consequence of the early access programme, and where not, that it would not take long to establish them. It heard that when the reduced treatment duration for the combination regimen of interferon with sofosbuvir is taken into account (12 weeks instead of 30 weeks) it would not be unreasonable to expect the existing capacity to be capable of treating a higher volume of patients.
5.12 Consultees pointed out that although many patients are expected to wait until all‑oral regimens are available, those with stable cirrhosis at risk of decompensation or hepatocellular carcinoma, will decide that it is better to have treatment now than to delay. These people will not be served by NHS England's early access programme which is restricted to people with decompensated liver disease. NICE noted stakeholders' suggestions for specific groups that might need special consideration if funding for all is not immediately required; that is, those co‑infected with HIV, gay men, drug users, and those for whom current treatment is having a detrimental effect on physical or mental wellbeing. NICE accepts these concerns but is satisfied that NHS England will now be putting in place measures to accommodate these patients as well.
5.13 NICE heard from Gilead that although it welcomed any opportunity to improve the current hepatitis C service model that may further enhance patient access and outcomes, the submission by NHS England provides no evidence that the proposed hepatitis C network is required for the implementation of the recommendations in this guidance. In particular, while a more sophisticated approach may be preferred in the context of the increase in the number of patients with chronic hepatitis C infection who would be expected to present for testing and treatment after implementation of fully oral interferon‑free regimens for the non‑cirrhotic group, Gilead believes there is no requirement for this approach for the implementation of this guidance – and NHS England has provided no evidence indicating that this would be the case. NICE understands that Gilead takes the position that in contrast to NHS England's assertions, the available evidence points to the fact that implementation of this guidance is very unlikely to result in substantial numbers of additional patients and indeed, will relieve rather than add to the existing burden on hepatitis C services.
5.14 NICE fully understands the concerns put forward by consultees who object to the proposed extension to the period of deferred funding. Any additional delay in accessing recommended treatments is, of course, undesirable. However, NHS England's plans to put in place an enhanced infrastructure reflect a real concern that the current arrangements expose the service and its patients to the risks associated with poor care coordination and inadequate resources. These concerns, though they may be disputed and must be balanced against the disadvantages of delayed access, are based on an arguable case. In addition, it is clear from its initial proposal and from its response to consultation that NHS England is making a considerable effort to ensure that patients for whom a delay in access to sofosbuvir represents a serious medical risk will have access to it under the existing and planned interim commissioning policies.
5.15 An extension to the deferred funding period, to 31 July 2015, is therefore granted under section 7(5a)[ii and iii] of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013; the health technology cannot be appropriately administered until 'certain health service infrastructure requirements including goods, materials or other facilities, or other appropriate health services resources, including staff are in place'.
5.16 When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in paragraph 5.1 above. This means that, if a patient has chronic hepatitis C and the doctor responsible for their care thinks that sofosbuvir is the right treatment, it should be available for use, in line with NICE's recommendations.
5.17 NICE has developed tools to help organisations put this guidance into practice (listed below).
Costing template and report to estimate the national and local savings and costs associated with implementation.