21 May 2015

NHS England accused of interference over hepatitis C drug

Officials at NHS England have been accused of interfering in a process to decide whether a drug which can cure Hepatitis C should be made available to patients on the health service.

Harvoni, which is a combination of two new generation hepatitis C drugs, is currently being appraised by the National Institute for Health and Care Excellence.

But at a meeting at NICE on April 1, it is claimed that two senior NHS England officials reminded those attending that they had to take into account the cost to the health service when deciding whether to approve any treatment.

This is, in fact, not true. NICE does not focus on affordability but rather on cost-effectiveness.

It is also claimed that the officials suggested that if NICE reached the wrong decision in appraising the drug, they would seek judicial review. Charles Gore, chief executive of the Hepatitis C Trust, told Channel 4 News: “I definitely felt they were suggesting that if NICE did not conform to what they would like to see happen, then they would potentially take judicial action.

“I definitely got the impression there was a threat there and that NICE should conform or face potential serious actions.”

In a statement, NICE told us: “Like other stakeholders, they (NHS England) have given us their views on how the evidence for using the drugs should be interpreted. NHS England are not acting in any way which would compromise the independence of our work.”

NHS England failed to answer our specific questions but in a statement they said: “NHS England is very supportive of expanded new treatment options for people with Hepatitis C, and has already begun funding their care. We also want to ensure that unresolved questions about the best treatment strategies are answered, and that phased investment in Hepatitis C services does not cause damaging cuts elsewhere.”

As many as 214,000 people in the UK are believed to be infected with hepatitis C. It can lead to cirrhosis of the liver and cancer. Some patients need to have transplants. And in the worst cases, sufferers die. Until recently the treatment lasted up to 48 weeks and had serious side-effects.

The new generation of drugs have been hailed as a breakthrough. There are far fewer side effects and a 92-98 per cent cure rate in some cases.

In January, NICE approved Gilead’s drug, Sofosbuvir.

Despite its cost – £35,000 for a 12-week course – they decided that it was of value because of its high cure rate, fewer side-effects and potential to prevent the need for costly liver transplants.

But there was outrage after they agreed to a request by NHS England for an unprecedented six month delay in implementation.

There is further concern that an early access scheme, so patients with cirrhosis did not have to wait the six months, has not yet started.

An employee checks a hepatitis B vaccine, at SciVac's laboratory in Rehovot

Harvoni – the drug currently being appraised – is a combination of Sofosbuvir and Ledipasvir.

Gilead is charging the same amount as they do for Sofosbuvir alone. Yet, we have been told that at the April 1 meeting the NHS England officials claimed it would cost £1.3bn if approval was given.

Mark Thursz, professor of hepatology at Imperial College London, said this was “a gross exaggeration”: “The likely cost is £300m to £400m because lots of patients who have cirrhosis have still not been diagnosed.”

He also said even if they were told they could treat 6,000 patients with cirrhosis it would take two years.

NHS England asked for a meeting this month to be delayed while they reassessed their figures. In the meantime, doctors are finding themselves unable to treat their patients.

Dave Gort, is a 37-year-old man with haemophilia. He was infected with Hepatitis C through contaminated blood 22 years ago. Last year he was told he now had cirrhosis of the liver but his consultant said that if he waited he would be given the new drugs.”We went to see him in January,” Mr Gort said. ” He told us it wasn’t yet available but it would be in April.

“We went back in April and he said he was sorry, it still hadn’t happened. So I decided to use my own money and pay for the treatment.”

In fact, the money Mr Gort used was from the ex-gratia Skipton Fund, set up for people who were infected by the tainted blood.

When his cirrhosis was diagnosed he received £50,000. He has now spent £45,000 on Harvoni (it is more expensive on a private prescription).

This is for a 12 week course, and he told us that within two days he began to feel better. And when we spoke to him earlier this week, his blood results showed what seemed to be an improvement.

However, if it does not clear the virus, Mr Gort faces paying for another course.

His final bill could be as much as £100,000.

Follow @vsmacdonald on Twitter


, ,

Tweets by @vsmacdonald