Patients could be denied access to a groundbreaking drug that cures Hepatitis C because the NHS cannot afford it, HSJ has learned.
In a move described as setting a “dangerous precedent”, an internal NHS England briefing note - seen by HSJ - describes the cost of offering the drug Sofosbuvir to patients as suggested by the National Institute for Health and Care Excellence as “prohibitive”.
The note puts the price tag of prescribing the drug in line with NICE recommendations of £1bn in 2015.
The internal briefing proposes more than halving the cost by prioritising patients “according to severity of liver disease”, and continuing to treat patients with drugs NHS England accepts are less effective and can cause serious side effects for many patients.
NHS England has become so concerned about the potential financial impact of Sofosbuvir it has asked NICE to extend the deadline by which the NHS must start to offer the new drug to patients, HSJ understands.
NICE provisionally recommended the drug for use by the health service in August and is due to issue its final decision on the use of the drug in November.
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Once final approval is given, the NHS would usually be expected to offer the drug to patients within three months.
HSJ understands NHS England has asked for the extension while it waits for other similar drugs to become available before deciding which ones to fund.
The briefing note said a “key aim is to maximise procurement levers and ensure competition within the market to get best value for money on drug pricing”.
Clinicians and patient groups told HSJ it was unacceptable for patients to be made to wait in this way.
Charles Gore, chief executive of the Hepatitis C Trust, said it appeared patients with hepatitis C - which disproportionately affects disadvantaged groups - were being unfairly targeted in NHS England’s bid to balance the books.
“Sometimes I question whether this is because of the demographic who have hepatitis C,” he said.
“I doubt if this same affordability question would be there in the face of a cost effective treatment for cancer.
“NHS England needs to accept that they’re going to have to pay for these drugs because they’re cost effective. They need to step back from this year’s budget and think about it in a strategic way.”
One senior clinician who treats patients with hepatitis C said clinicians needed flexibility in making treatment decisions, not a central diktat rationing who could and could not be treated.
“If you were a young woman planning a family you would not want to be told you had a one in 20 chance of giving birth to a child with a cancer causing virus [hepatitis C] when you could have an eight week course of treatment,” he added.
“I would be very disappointed if the NHS forces patients to wait until they’re ill enough.
“This would set a dangerous precedent that the NHS is only going to treat people with severe disease.”
Stephen Whitehead, chief executive of the Association of British Pharmaceutical Industry, described it as “alarming” that any medicine approved by NICE “might then be subject to further hurdles that could impede patient access”.
“Whilst I understand the cost pressures facing the NHS, NICE have clearly stated the value of this medicine in terms of long term reduction of cost.
“The solution is to work in close collaboration to ensure that innovation is seen as an opportunity and decisions aren’t driven by short term cost concerns at the expense of a longer term burden.”
NHS England’s £1bn cost estimate assumes the drug would be prescribed to up to 20,000 patients, which its hepatitis C clinical advisory group believe could benefit from the treatment.
However, some sources close to the discussions questioned whether the price tag would be so high.
Sofosbuvir, which is marketed by Gilead as Sovaldi, has been found to cure up to 90 per cent of patients with hepatitis C, in combination with other drugs.
A spokeswoman for the firm said: “We know that NHS England have been working on a plan for the introduction of this medicine since 2013 and we would be very happy to work with NHSE to create a robust estimate of the impact on their budget in order toplan for prompt implementation of NICE guidance.”
Its own feedback from doctors which treat liver patients in the UK suggested the availability of Sovaldi was “likely to lead to a two-fold increase in the numbers of patients treated per year, from 5000 to 10,000,” he added.
“Sovaldi will replace 24 to 48 week courses with current therapies which will is likely to free up resource to manage the expected increase in patient numbers.”
NHS England said it had funded early access to sofosbuvir for 500 patients earlier this year.