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UK Delays Sofosbuvir Access Blaming Unprepared
Infrastructure Despite EMA Approval
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Download The PDF Here
Excerpts from attached document:
"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."
"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"
"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......
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 multi-disciplinary team approach to care. ......
The establishment of a national database and dashboard to monitor and support individual care
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 to the deferred funding period to the end of July 2015 were to be made available.
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). "
"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 1st 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 (MDT) 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. "
"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 well-being. NICE accepts these concerns but is satisfied that NHS England will now be putting in place measures to accommodate these patients as well."
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.
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Patients Blame Cost for Coverage Delay in England of Gilead Drug
Jan 22 2015
http://blogs.wsj.com/pharmalot/2015/01/22/coverage-for-gileads-sovaldi-is-delayed-in-england-over-cost/
England's taxpayer-funded health system is postponing the introduction of Sovaldi for most hepatitis C patients until the end of July, a delay patient advocates believe is closely tied to the cost of the controversial drug.
The Europe Union's main pharmaceutical regulator, the European Medicines Agency, approved Sovaldi a year ago, in January 2014. Soon after, England's pharmaceutical cost watchdog, the National Institute for Health and Clinical Excellence, began reviewing Sovaldi to determine whether it was cost effective. NICE has since ruled that it is, indeed, cost effective.
Typically, England's National Health Service accepts NICE's rulings and begins offering the drugs NICE endorses within 90 days. But the NHS says extra time is needed to put its clinical infrastructure in place to cope with what it anticipates will be a "substantial demand" for Sovaldi, according to a document NICE published on January 16.
England, we should note, is getting a big discount over the U.S. wholesale price for Sovaldi. Gilead Sciences GILD +1.48%, which sells the drug, is charging England $52,500 for a 12-week course of the drug, versus the $84,000 it charges for a 12-week course in the U.S.
Among its arguments for a delay, NHS England says it needs time to establish a network of specially trained treatment centers. In its January 16 ruling, NICE said it is allowing NHS England to delay Sovaldi provision by 180 days instead of the standard 90 days. The delay was first reported, by the way, by The Guardian.
"NHS England is clearly concerned about its ability to make sofosbuvir (the chemical name for Sovaldi) available in the way it considers necessary for planned, efficient and properly audited care," NICE says in the document.
Advocates for hepatitis C patients say England already has robust treatment infrastructure in place. "I don't think that NHS England's reasons for asking for the delay stand up to scrutiny, which makes me believe this is a cost issue," says Charles Gore, chief executive of the Hepatitis C Trust, a non-profit group based in London. "I believe having delays on the grounds of cost is very dangerous. Once you allow the idea that we can't afford it to trump cost effectiveness, you've changed the entire cost effectiveness system," he said.
Asked whether the delay essentially comes down to cost, the NHS told us it's "to ensure equitable access to care." The NHS adds that it has been providing Sovaldi on a case-by-case basis since June 2014, to patients who meet "specified clinical criteria," including a risk of liver failure. NHS England says it will also ensure that as of April this year, the drug is available for patients with "less severe forms of cirrhosis."
But it looks like widespread availability will have to wait until the end of July.
In the Jan 16 document, NICE says Gilead saw little need for the delay. "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," the NICE document says.
We asked Gilead for comment and will update you accordingly.
In the meantime, a NICE spokesman tells us the watchdog is currently reviewing AbbVie's new hepatitis C drug regimen to determine whether it, too, is a cost-effective use of England's resources.
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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.
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