Patients will be put at risk of developing cancer after NHS England was granted permission to delay access to a groundbreaking cure for hepatitis C, patient groups have warned.
In guidance published today, the National Institute for Health and Care Excellence said it had agreed to NHS England’s request to extend by three months the timetable for implementing NICE recommendations on the drug Sofosbuvir.
NHS England now has until the end of July to make the drug available in line with NICE recommendations.
The documents say that NHS England had requested the delay due to concerns over the time needed to provide the necessary infrastructure to provide the medicine. However, a patient group claimed the real reason was the high cost of the drug.
HSJ reported last year that an internal NHS England briefing note described the cost of offering Sofosbuvir to patients as “prohibitive”. A 24 week course of the treatment costs £69,965, excluding VAT.
The note put the price of prescribing the drug in line with NICE recommendations at £1bn in 2015.
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Charles Gore, chief executive of patient group the Hepatitis C Trust, said: “I’m disappointed in NICE. [The decision to delay] may have been done before but it seems to me to be a very precedent setting that things can be delayed because of the cost.
“Those are not the grounds under which NHS England has requested the delay, because they are not allowable, but they are the real reason.”
Mr Gore added: “There will be people with cirrhosis who would have got the treatment from now if it had not been delayed so much.
“Some of those people with cirrhosis who now won’t get [treatment] until April - and that’s assuming that NHS England sticks to its timeline - will develop liver cancer between now and April.”
About a third of people infected with the hepatitis C virus will eventually develop liver cirrhosis, where normal liver tissue is replaced by scar tissue. A small number of people with chronic hepatitis C and cirrhosis also go on to develop liver cancer.
In August NICE provisionally recommended the drug, marketed by manufacturer Gilead Sciences under the name Sovaldi, for use by the health service.
Updated draft NICE guidance on Sofosbuvir, issued yesterday, stated: “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.”
A senior clinician working with hepatitis C said: “It’s perfectly reasonable of NHS England to say ‘let’s try and set up a process of stratifying patients, making sure we give the right people the right treatment first’.
“However, hidden away in the detail of the guidance there’s actually probably 5,000-10,000 people with hepatitis C cirrhosis, many of whom could get into real trouble over the next six months and many of those, if treated, would not run into trouble.”
NHS England said in a statement: “In all cases where NICE recommends new drugs or treatments, it includes a 90 day period of time for implementation. NHS England have asked NICE to consider extending the implementation period to 31 July 2015 in order to allow formal clinical networks for hepatitis C to be established in order to ensure equitable access to care.
“Until NICE’s final guidance on Sofosbuvir comes into effect, NHS England has in place an interim commissioning policy on Sofosbuvir with Ledipasvir or Daclatasvir since June 2014, and formed an interim policy for Simeprevir which makes these treatments available to patients meeting specified clinical criteria. So far, NHS England has made an additional £38m available in 2014-15 to cure patients at risk of liver failure.
“In addition, NHS England has made an assessment of need for patients with less severe forms of cirrhosis who may require treatment from April 2015, and will be finalising its plans shortly on the treatment options for this wider patient group.”