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Wednesday, May 7, 2014

Gilead's Sofosbuvir- NHS forced into emergency action to fund ‘game-changing’ Hep C drug

 Also View - UK - 'Eradicating hepatitis C is a realistic aim'

Wednesday 07 May 2014

NHS forced into emergency action to fund ‘game-changing’ Hep C drug 

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Channel 4 News understands that NHS England has taken the unusual step of setting up an emergency access scheme for a new hepatitis C drug after plans for fast track funding were delayed.

Three weeks ago, we revealed that NHS England had agreed to early funding of the drug, Sofosbuvir, for 500 patients with a severe form of the disease who were otherwise likely to die or to need a liver transplant within a year.

However, no patient has yet received the drug after it emerged that NHS England had not worked out a procedure for moving the funding to the doctors who wanted to prescribe the drug.

Now after pressure from consultants and the Hepatitis C Trust, NHS England has agreed to the emergency scheme for the most desperately ill of those 500 patients. We have been told that the funding will reach doctors by Monday.

In our piece three weeks ago, we interviewed Nils Nordel, of Oxford, who contracted the disease following dental treatment in Egypt 20 years ago.

Since then, Mr Nordel’s condition has deteriorated. Rather than wait for NHS England to work out the funding problems, his doctors have now gone straight to the drug company, Gilead.

Mr Nordel’s consultant, Dr Ellie Barnes, said that Gilead had agreed to supply the drug and Mr Nordel should be able to begin the treatment on Friday.

Dr Barnes said Gilead had acted somewhat on faith, on the understanding that Mr Nordel’s name would be on the emergency funding list.

Breakthrough treatment

The drug has been hailed as a “game changer” because it has a 90 to 95 per cent cure rate, can prevent the need for transplant and has almost no side effects.

Until now, there have been few options for people with the advanced effects of hepatitis C except a liver transplant.

The current drug regime, using interferon, with other drugs such as ribavirin, cannot always be tolerated by those with the more serious form of the disease.

Even for those who can take it, the regime has serious side-effects and is not, more crucially, a cure.

Mr Nordel has now been assessed for a liver transplant and it is not clear whether the drug will prevent that operation from having to go ahead.

There is some evidence that the drug can reverse some of the damage to the liver caused by the disease, although no studies have been done on patients as seriously ill as Mr Nordel. And there is also evidence that the number of days that a patient is virus-free before a transplant increases the likelihood that the virus will not attack the new liver.

Dr Barnes said that in these cases, “days matter” when it comes to getting the treatment to the patient.

Bureaucratic delays

Consultants have welcomed the fact that funding was agreed by NHS England, but criticism and frustration will escalate if the funding process is not streamlined over the coming days as promised.

It appears, though, that the organisation may have fallen foul of the “any qualified provider” rules introduced under the NHS reforms that insist that processes like this are put out to tender.

This means that although it was agreed 15 centres should be responsible for getting the drug to the patients, private providers – who probably have no interest in being involved – still had to be given the opportunity to be part of the process.

One consultant told Channel 4 News that it was an “appalling system” that meant NHS England had been forced to make the early access scheme up as it went along.

The early funding was agreed, after a three month process, because it was recognised that the National Institute for Health and Care Excellence (NICE) would not be able to evaluate the drug quickly enough for the most seriously ill.

The drug is expensive – £35,000 for a 12 week course. But when compared with the need for a liver transplant, followed by a lifetime of drugs, it becomes highly cost-effective.

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See more at: http://blogs.channel4.com/victoria-macdonald-on-health-and-social-care/nnn/2127#sthash.kNKf9pKE.dpuf

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