Keywords: UK, NICE, Bayer, Nexavar, Liver cancer,

UK’s NICE again rejects Bayer’s Nexavar for advanced liver cancer, but company can, and will, appeal

Article | 19 November 2009

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Following a further appraisal, the UK’s National Institute for Health and Clinical Excellence (NICE) has again decided against recommending the use of German drug major Bayer’s Nexavar (sorafenib) under the National Health Service for advanced hepatocellular carcinoma (HCC) in patient for whom surgery or therapies in the region the cancer arose have failed or are not suitable, essentially because the drug is too expensive.

Nexavar, which has been shown to extend life, including the quality of life, by several months, in the UK costs around £3,000 ($5,000) a month for treatment. It has been approved – and is routinely used – in most European countries, including the likes of Romania, which can hardly be described as one of the region’s rich countries.

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£9 million annual cost to NHS

The cost to the NHS of treating them would be £9 million a year, a spokesman for NICE said, although Bayer, has offered to pay for every fourth packet of treatment bringing the NHS cost down to £7.7 million, which the NICE still deems too much.

Nexavar, which generated global revenues for the company of 462 million euros ($691.2 million) in 2008, has been approved in more than 70 countries for advanced kidney cancer, and more than 60 countries for liver cancer. Sales advancing by a currency-adjusted 29.6% to 161 million euros for the third-quarter 2009. After an initial rejection in May, Bayer submitted a new patient access scheme whereby the company offered to pay for every fourth pack of the drug. More than 3,000 people are diagnosed with liver cancer every year in the UK and their prognosis is generally poor. Only about 20% of patients are alive one year after diagnosis, dropping to just 5% after five years.

In line with the NICE technology appraisals process this draft guidance is now with consultees, who have the opportunity to appeal against the proposed guidance. The agency notes that it has not yet issued final guidance to the NHS, said the NICE.

Andrew Dillon, Chief Executive of the 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.”

He added: “We have recently changed our approach to appraising high-cost treatments which can 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 being asked by Bayer is simply too high to justify using NHS money which could be spent on better value cancer treatments. The company, together with patient groups, professional associations and other consultees, now has three weeks to consider whether to appeal against our proposed guidance.”

Bayer will “fight hard”

A spokeswoman for Bayer in the UK told The Pharma Letter that the company will “fight hard” to get its Nexavar available for NHS patients in England, confirming that the company will appeal the NICE decision.

In its official statement, Bayer said that, while the NICE acknowledged that Nexavar is the only systemic treatment which could prolong the survival of eligible patients and meets its end-of-life criteria, it was rejected on the grounds that it was not a cost effective use of NHS resources, even in light of Bayer’s UK patient access scheme. The NICE does not appear to have acted in accordance with its own processes, the firm noted.

Nicole Farmer, business unit head of Bayer Schering Pharma Oncology in the UK, commented: “While we recognize that NICE has difficult decisions to make, we are without doubt that today’s guidance goes completely against UK HCC treatment guidelines, NICE’s own ’end of life’ criteria and the current government strategy to bring cancer outcomes in line with Europe. Bayer has proposed an excellent patient access scheme for Nexavar, unique to the UK, to enable patients in this country to benefit from this life-extending medicine. We believed we had satisfied NICE’s criteria for how Nexavar® would be assessed - however, the ‘goal posts’ appeared to have moved.”

Macmillan Cancer Support is “extremely disappointed,” saying it is “a scandal”

Responding to the decision by the NICE, Mike Hobday, head of campaigns at Macmillan Cancer Support, said: “We are extremely disappointed that NICE has decided not to recommend sorafenib as a treatment for people with advanced liver cancer. It is a scandal that the only licensed drug proven to significantly prolong the lives of people with this devastating disease has been rejected, leaving them with no treatment options. It’s time to rethink the way new cancer drugs are assessed to ensure fairer access to drugs for people with rarer cancers.”

Alison Rogers, chief executive of the British Liver Trust, added weight to the argument for Nexavar, noting that "the decision to reject a treatment for advanced liver cancer is a huge blow for patients. This is a treatment to extend life for people where all other options have run out. It is particularly hard for people with liver cancer given that treatments for many other advanced cancers have been given the green light by NICE. People with liver disease often face stigma and discrimination and sadly this decision feels like a further disadvantage to them.”