Sovaldi ‘cost effective but not affordable’ for NHS

A leading charity says new Hepatitis C drug Sovaldi is a huge step forward in treating the disease – but says its high price means it is not affordable for use on the NHS.

Gilead's Sovaldi (sofosbuvir) was launched in the US in December, and is already transforming the treatment of Hepatitis C, thanks to its ability to cure far more patients than existing treatments, with fewer side effects, and in a much shorter treatment period.

But the drug's high price has caused huge controversy in the US – it costs $84,000 for a 12-week course of treatment, which works out as $1,000 per pill.

The UK price is considerably lower than the US price, and is understood to be around £34,983 for a 12 week treatment– but the cost is causing concern here too.

Charles Gore, chief executive of the UK charity the Hepatitis C Trust says Sovaldi is a genuine 'step change' for patients, but that the NHS cannot justify spending so much on one treatment.

The drug was officially launched in the UK in February, but patients in England are still not receiving the drug because NHS England, which is now in charge of specialist commissioning, is still deliberating over the drug.

Charles Gore, who sits on two specialist committees examining the drug's introduction to the health service, says there NHS England and Gilead will inevitably have to negotiate on the drug's price.

He said: "They [NHS England] are going to look at the numbers and say 'this is not doable.' "

NICE likely to say yes

Unlike a lot of other new high cost drugs, Sovaldi is actually predicted to gain NICE approval with relative ease.

This is because of compelling data - it can cure far more patients (up to 90%) with fewer side effects and in a fraction of the time compared to existing treatments (down to 12 weeks from 24 weeks) which means the drug is likely to be judged as 'cost effective' by NICE, despite its high cost.

Charles Gore says: "It will sail through NICE, I'm reasonably certain, because of the figures and because it is a cure." But he says ruling a drug 'cost effective' is not the same as it being 'affordable' – and predicts that NHS England will reach the same conclusion.

NICE is set to make its initial recommendation on Sovaldi in May, with a final decision expected in October. But Gore predicts that NICE's ruling won't be enough to ensure patients gain access to the drug.

"It will be cost effective – but that's not the issue – the issue is, is it affordable?" There is no point saying 'NICE say it's OK, we want it'. It has to be affordable."

Is restricted access ethical?

The NHS in England is currently treating 5,000 Hepatitis C patients a year, and around two thirds of these are being cured by current treatments.

This statistic suggests that NICE could eventually rule that only those who remain uncured by existing treatments should be given Sovaldi. This, or another way of limiting access to the drug, would be typical of NICE's previous attempts to limit expense to the NHS.

But Charles Gore says such rationing would be ethically 'indefensible' and called on Gilead and NHS England to find a way to make the drug as widely available as possible.

Asked if he had told Gilead that Sovaldi was overpriced, Gore said: "It's actually not my business to tell them about price, that's the government's job. What I want is it to be affordable for everyone. That's to do with NHS budgets, that's not our place as a patient group."

Gore says he understands the need of the industry to recoup its R&D costs, but also believes that the NHS cannot cope with the 'burgeoning drug budget'.

"These are two powerful organisations - the pharmaceutical industry and the government – they are perfectly capable of slugging it out and coming up with an agreement."

Potential to wipe out Hepatitis C

Sovaldi is in fact just the first of a new generation of drugs which are set to transform treatment of the disease, which is transmitted through contact with infected blood. The efficacy of the new drugs is such that there is now talk of eliminating the disease entirely.

Janssen, AbbVie, Merck and Bristol-Myers Squibb all have drugs in late-stage development which could bring cure rates up to around 100 per cent. While healthcare systems around the world hope that competition among these rivals will help trim prices, their availability means spending on Hepatitis C will increase hugely.

In England, the 5,000 patients who are treated every year are just the tip of the iceberg – they represents just 3% of the estimated 165,000 people infected in the country.

The Hepatitis C Trust calculates that if the number being treated each year rose to 20,000 patients, this would bring it the point where the disease could be eliminated. However this would require a very substantial increase in screening for the infection, which individuals often unknowingly carry for decades, until symptoms emerge and serious damage to their liver has been done.

Charles Gore says he thinks current UK mechanisms for negotiating with pharma companies is not robust, but believes an agreement can be reached. The charity is pushing for early access to the drugs for the most critically ill patients, and NHS England says an announcement on this question will be made in May.

Links

WHO highlights 'unaffordable' Hepatitis C treatments

NHS England's delay on Sovaldi risking lives, says charity