Source: The Gaurdian
16 Jan 2015
The NHS is to delay the introduction of a highly expensive drug that can save the lives of people infected with the hepatitis C virus. The move by NHS England is unprecedented, because the NHS rationing body, Nice (the National Institute for Health and Care Excellence) has approved the drug. Nice says sofosbuvir is cost-effective, because it is a cure for people who would otherwise run up huge NHS bills.
One in three people infected with hepatitis C will develop liver cirrhosis and some will get cancer. A liver transplant costs more than £50,000.
But NHS England appears to be balking at the bill for the drug, which would hit £1bn for every 20,000 people treated. Approximately 160,000 people in England alone are infected with hepatitis C, although fewer than half are aware of it.
Sofosbuvir has been hailed internationally as a breakthrough, but there is global concern over the very high cost of a drug that can save lives. Campaigners are pressing for lower prices, from the US – where it costs $1,000 a pill – to India, in a fight which they liken to that over drugs against another virus: HIV, which causes Aids. On Wednesday, they celebrated a decision by the Indian authorities not to allow a patent application for sofosbuvir by Gilead, the manufacturer, which means Indian companies may be able to make cheap copies for the developing world.
The price offered by Gilead in the UK is almost £35,000 for a 12-week course. Many patients will need a 24-week course, costing £70,000. Inits final draft guidance on sofosbuvir, Nice said it was allowing NHS England to postpone implementation for four months, until the end of July instead the beginning of April. NHS England failed to comment.
Charles Gore, chief executive of the Hepatitis C Trust, said he was very concerned about the delay. Nice had allowed NHS England to make a decision based on affordability rather than cost-effectiveness. “It feels to me as if a whole new criterion has been invented by the backdoor,” he said. If the NHS could delay using a new drug by four months, it could also delay by six months or a year – or it could decide on the basis of its cash-strapped budget to use it one year but not the next.
“It is undoubtedly a high cost,” said Gore. “The unfortunate thing is there are an awful lot of people who need it. We’re talking about potentially hundreds of thousands of people. That becomes a massive budget-buster.”
NHS England has introduced a scheme to pay for the treatment of people who are very ill – many of them on liver transplant waiting lists. In April, it announced an £18.7m fund to pay for 500 patients with acute liver failure.
But Mark Thursz, professor of hepatology at Imperial College London and chair of the Hepatitis C Coalition, said there were others who needed treatment as soon as possible. “The delay is unprecedented,” he said. “What worries me about it is that if you have got advanced liver disease with hepatitis C, you could progress at any stage to the point where it is very difficult or impossible to reverse the situation or have any improvement. Opportunities are being missed by any delay.”
About 10,000 to 15,000 of people with hepatitis C infection in the UK have cirrhosis, he said. Around 5,000 have advanced disease and need treatment soon if they are not to suffer long-term damage.
Hepatitis C is spread by contact with infected blood. Some people live with it unknowingly for years having injected drugs in their youth, while some got it from blood transplants before screening for the virus was introduced. It is also thought to be spread by sharing razors or toothbrushes with those infected.
There are older drugs but the treatment lasts up to four years and has serious side-effects, including depression. Sofosbuvir is a once-daily pill, taken with one or two other drugs for 12 or 24 weeks
Stelios Karagiannoglou, Gilead’s general manager, UK and Ireland, said the company was pleased with the Nice decision. But he added: “We are disappointed that the majority of patients will not gain access to this important medicine until later this year.” He called on NHS England to commit to a scheme from April offering early treatment for people with cirrhosis.