NICE yes for two new hepatitis C drugs

But NHS England has balked at the plans, saying it cannot afford to pay for sofosbuvir

NICE is now recommending that two new but costly hepatitis C pills should be funded by the NHS, but NHS England says it will not pay for sofosbuvir until later this year, given its high price tag.

In final draft guidance published today simeprevir (Olysio), in combination with peginterferon alfa and ribavirin, and sofosbuvir (Sovaldi), have both been recommended for treating certain hep C patients.

Simeprevir has received a NICE recommendation for treating as an option for treating both genotypes 1 and 4 chronic hepatitis C in adult patients.

This is a reversal of NICE’s previous draft guidance which had said the drug was too costly for the NHS. New data from the drug’s manufacturer has now managed to convince the pricing watchdog that it is in fact cost-effective.

NICE is also recommending that sofosbuvir be recommended for genotypes 1 through to 6 (under certain conditions) and to include more people with chronic forms of the disease.

This is also a U-Turn on a previous negative decision by NICE, which had asked the drug’s manufacturer Gilead to provide more information on the effectiveness of its pill in these patient populations.

But this is only part of the story: whilst sofosbuvir will likely be given a yes in NICE’s final guidance by April of this year, in an unprecedented step NHS England has told NICE it will not fund the drug until the end of July in an attempt to save money.

Documents from NHS England seen by Prescriber last year showed that the NHS England was concerned over the costs of the pill and was considering such a delay.

Sofosbuvir has shown in late-stage clinical trials to be highly efficacious, effectively curing around 90% of patients.

This can reduce and in most cases remove the need for a liver transplant, something that costs around £50,000 per patient and comes with a risk of rejection, and the need to take extra medication for the rest of the patient’s life.

But with this high efficacy has come a high cost: sofosbuvir costs around £35 000 per patient for a 12-week course of treatment – far higher than most biologics for cancer or auto-inflammatory diseases. A 24-week treatment comes in at £70 000.

But the cost of treating all of the patients under the NICE recommendation means the NHS in England would spend around £1bn for every 20,000 people treated – nearly a tenth of the entire drugs budget.

Around 160,000 people in England alone are infected with hepatitis C, although fewer than half are aware of it. NHS England has said it will look to introduce an interim policy from April to allow the drug to be used by advanced patients in combination with other medicines.

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.”

But NHS England will soon face a similar quandary if Gilead’s follow up hep C pill, sofosbuvir plus ledipasvir (Harvoni), also gains NICE approval.

According to MIMS, this will cost around £39,000 per patient for a 12-week course (without the use of ribavirin) – although Gilead says many patients can achieve a clinical cure within eight weeks, reducing the cost.

Sofosbuvir plus ledipasvir is also more efficacious than sofosbuvir on its own, achieving up to a 98 per cent success rate in clinical trials. The drug is now under NICE appraisal but given the latest recommendation of sofosbuvir, it is likely that the watchdog will also clear the combination treatment.

It remains to be seen whether NHS England will also look to delay this treatment.

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