Government promises new money for cancer drugs after NICE rejects liver cancer treatment

The new coalition government has reiterated its pre-election promise to give patients access to expensive treatments by emphasising the advisory nature of guidance from the National Institute for Health and Clinical Excellence (NICE) after the agency rejected a drug for the treatment of advanced liver cancer for use on the NHS because of its cost.

NICE guidance on sorafenib (Nexavar) for the treatment of advanced hepatocellular carcinoma says the drug should not be used in the NHS because its high cost cannot be justified by the small benefit it gives patients.

In response to the guidance the department of health said that primary care trusts should “consider carefully whether there are particular local or individual circumstances that would make it appropriate to fund sorafenib, or other drugs NICE has been unable to recommend for routine use.”

The spokesperson said the department would be setting up a new cancer drugs fund to operate from April 2011. In the meantime it will be looking at joint payment schemes with drug companies “which will enhance access for patients to costly medicines.”

Although it respected “the expert independence of NICE” the department said there would be significant reforms to the way which drugs are funded “so that we can give effect to our intention that patients can access the drugs most clinically effective for them; and that the price paid by the NHS reflects value for money.”

The statement added, “We believe that it [NICE] must be allowed to continue to issue guidance free from political interference. However, we believe that there are fundamental failings within the wider system for drug pricing and access. We are determined to address this and are clear that NICE plays a vital advisory role.”

NICE considered sorafenib under its end of life drugs treatments framework and took account of an offer by manufacturers Bayer to pay for some of the cost. But even so it calculated that the lowest cost per quality adjusted life year (QALY) gained for the drug was £52 600 (€61 620; $76 560) with the highest end of the range costing substantially more.

NICE typically recommends the NHS to use treatments when they fall within a range from £20 000-30 000 per QALY. But for end of life drugs the QALY threshold can be extended to £40 000-50 000.

The trial evidence seen by NICE’s independent advisory committee showed that sorafenib increases survival by an average further 2.8 months, but at a cost of £27 000 per patient. Half of the patients who benefit from the treatment survived for less than 2.8 months.

Bayer appealed against the guidance in February, but this was dismissed by the Appeal Panel.

Andrew Dillon, Chief Executive of NICE, said, “We were disappointed not to have been able to recommend the use of sorafenib, but after carefully considering all the evidence, including the proposed ‘patient access scheme’, in which the manufacturer offered to provide every fourth pack free, sorafenib does not provide enough benefit to patients to justify its high cost.

“We have changed our approach to appraising high cost treatments which can potentially extend life for terminally ill patients. This has meant that more of them are now being recommended. We looked at sorafenib in just the same way but the price is simply too high to justify using NHS money which could be spent on better value, more effective cancer treatments.”

He said that NICE will be happy to work with the new government when it outlines its scheme.

He added, “The government decides how the NHS should use the funds made available to it and if it considers that treatments which would not routinely be made available should be paid for from a central fund, it is entitled to do so.”

The NICE guidance on sorafenib is at http://guidance.nice.org.uk/TA189