NICE says yes to Sovaldi – but some patients will miss out

New Hepatitis C treatment Sovaldi has been approved by NICE in a broad range of patients, despite concerns about a potentially huge cost to the health service.

The draft guidance from the NHS cost effectiveness watchdog is good news for Hepatitis C patients, and for pharma company Gilead, as NICE had originally indicated that it was minded to reject the drug.

NICE said in June that there was insufficient evidence to support the drug’s cost effectiveness, and asked Gilead to present detailed health economic data to back up its case.

The company has provided the data as requested, resulting today in NICE publishing draft guidance which recommends the drug for NHS use. But NICE has been careful to issue precise guidance on Sovaldi’s use, pinpointing which patient sub-types and stages of the disease it was found to be cost effective in, and which it was not.

A breakthrough – but a costly one

Sovaldi (sofosbuvir) has caused a stir around the world since it was first launched in the US last year – the drug offers a cure for many more Hepatitis C sufferers, speeds up the treatment process and has very few side effects – but this comes at a price.

In the UK, the drug costs nearly £35,000 for 12 weeks of treatment, and just under £70,000 for a 24-week course of treatment.

This is many times more expensive than existing treatments, but reflects Sovaldi’s ability to cure far more patients (up to 90 per cent) with fewer side effects and in a fraction of the time compared to older drugs (down to 12 weeks from 24 weeks).

This exceptional clinical offering has persuaded NICE to judge it to be ‘cost effective’ despite its high overall cost.

Gilead’s UK general manager, Stelios Karagiannoglou, said the company was “pleased that, following a very complex assessment, NICE has recognised the clinical and economic benefit of treatment with sofosbuvir and has determined it is a valuable use of NHS resources for the majority of Hepatitis C patients.”

But he noted that the some patients with specific sub-types of Hepatitis C would not be eligible to receive the drug under the NICE draft guidance. This is in contrast to the ruling by the Scottish Medicines Consortium, which cleared the drug’s use in a broader range of Hepatitis C patients in Scotland in June.

Charles Gore, the chief executive of the Hepatitis C Trust welcomed the new preliminary guidance, saying that it “takes us one step closer to making the elimination of Hepatitis C a realistic possibility by improving both cure rates and tolerability.”

However he said the trust was “equally disappointed that a small group of patients will not benefit.”

Most patients eligible

There are six major genotypes of Hepatitis C, but most patients in the UK have the genotype 1 or genotype 3 strain of the disease (46 per cent and 43 per cent, respectively).

NICE has recommended the drug’s use in patients with Genotype 1, in addition to standard treatments peginterferon and ribavirin, and it can be given to patients who have been treated already, or who are treatment naïve.

NICE said the drug (in combination with peginterferon and ribavirin) should be an option for most Genotype 3 patients, the other most common strain. But the watchdog says people who are treatment naïve without cirrhosis should not receive the drug – these are generally the more easy to treat cases, and therefore were judged not to require Sovaldi, which is far more effective in helping hard-to-treat cases compared to existing drugs. Consequently NICE found treating these patients not to be cost effective compared to existing treatment.

One of the biggest advantages of Sovaldi is that it can remove the need for some patients to also take peginterferon, an injection which causes numerous unpleasant side effects. This means patients need only take Sovaldi in combination with ribavirin. However NICE has recommended the drug in this setting in just a few instances. In patients with Genotype 2 it is recommended for (i) those who have not had treatment for chronic Hepatitis C before and are intolerant to or ineligible for interferon therapy or (ii) have had treatment for chronic Hepatitis C before, regardless of interferon eligibility.

Finally, Sovaldi in combination with ribavirin is recommended as an option for treating genotype 3 chronic Hepatitis C only in adults with cirrhosis.

Disease time bomb – and a cost time bomb?

An estimated 160,000 people are chronically infected with the Hepatitis C virus in England – but more than half of these are unaware, as they only have mild or no symptoms for a long period of time.

Around a third of people infected with the Hepatitis C virus will eventually develop liver cirrhosis, which causes grave health problems, and can require a liver transplant. A small percentage of people with chronic Hepatitis C and cirrhosis also develop liver cancer.

This means that the UK, like many other countries, is sitting on a Hepatitis C ‘time bomb’, with many currently infected patients expected to become seriously ill when their disease progresses over the coming decades.

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

The cost implications of widespread Sovaldi use are clear – If all existing patients were given the drug, it would cost the NHS in England an extra £175 million. The new NICE guidance means this is unlikely to happen, however an upsurge in new cases will create new cost for the health service.

The current number of HCV patients who are diagnosed and undergoing treatment is just the tip of an iceberg.

If all 160,000 currently infected people in England were diagnosed and treated with the drug, the cost would come to an astonishing £5.6 billion – around half the current medicines expenditure for the UK.

This is an extreme scenario, but the extent to which health services will be able to identify and treat these tens of thousands of undiagnosed patients remains uncertain.

In April, the Hepatitis C Trust’s chief executive Charles Gore told pharmaphorum that he predicted Sovaldi would be approved by NICE – but that the NHS would nevertheless judge it ‘unaffordable’ because of these cost pressures.

This could lead local NHS bodies to seek ways to limit their spending on the drug, for instance reserving its use for those who remain uncured by existing treatments, despite this being contrary to NICE draft guidance.

In the US, the drug’s cost is $84,000 for three months’ treatment, and its high price has led to huge concern over the cost to the health system there.

The US Senate Finance Committee has asked Gilead to provide it with detailed information about how it arrived at its price, and health insurers have declared outright opposition to the cost of the drug.

NICE has not yet issued its final guidance – a consultation period now follows, ending on 5 September.

A number of rival drugs to Sovaldi are fast approaching the market, and the Hepatitis C Trust has urged NICE to prioritise these for review.

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Sovaldi ‘cost effective but not affordable’ for NHS

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