Gilead's Harvoni gains NICE yes - but won't face funding delay - genotype 1, 4 , but not genotype 3

Gilead's Harvoni gains NICE yes - but won't face funding delay

Unlike the company's Sovaldi, which won’t be paid for until the summer

Gilead's next generation hepatitis C pill Harvoni is set to be backed by NICE - and this time NHS England won't be delaying its funding as it has done with the firm's other hep C drug Sovaldi.

In draft guidance, NICE is recommending Harvoni (ledipasvir-sofosbuvir)as a treatment option for some adults with genotype 1 or 4 chronic hepatitis C.

Last month the drug pricing watchdog also gave Gilead's Sovaldi (sofosbuvir) its backing in final guidance – but while its £35,000 price tag was deemed cost-effective by NICE, NHS England has controversially said it will delay funding the treatment until August - two months later than it would usually have been paid for.

The commissioning body, which has control of around 40% of the total £105bn annual NHS budget in England, said that if Sovaldi was used by every patient in its licencing remit, the cost would top £1bn - and it says this is 'prohibitive'.

But the same decision has not been made regarding Harvoni - a drug that costs slightly more than Sovaldi at just under £39,000, but which can be taken over a shorter period of time and without the need for injectable drugs, which Sovaldi requires.

NICE told PMLiVE that it had been “given no instruction from NHS England that funding would be delayed for this drug”, leaving the reasons for the body's decision over Sovaldi in question.

The marketing authorisation for Harvoni specifically recommends treatment for genotypes 1, 3 (in combination with ribavirin) and 4.

Genotypes 1 and 3 hepatitis C account for the majority of chronic hep C cases in England (46% and 43% respectively). Genotype 4 hep C accounts for around 4% of cases.

Commenting on the draft guidance Professor Carole Longson, director of the NICE centre for health technology evaluation, said: “[Harvoni] offers the possibility of a shortened course of treatment - in some cases as little as eight weeks - without the need for combination therapy with interferon.

“The committee therefore acknowledged that ledipasvir-sofosbuvir is a valuable new therapy for treating chronic hepatitis C.”

The current cost for a liver transplant, which is what many late-stage hep C patients require, costs around £50,000, with a number of other costs relating to medicine treatment. NICE says that as Harvoni can effectively cure the disease, this wipes out the cost of liver transplants, helping make it cost-effective.

The committee also considered Harvoni in combination with Roche's injectable hep C drug Copegus (ribavirin) for people with genotype 3 chronic hepatitis C.

But based on the evidence presented, the Committee concluded that this “could not be considered a cost-effective use of NHS resources”.

Source

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