The National Institute for Health and Clinical Excellence has approved AstraZeneca’s Iressa and Roche’s Xeloda for use on the National Health Service, but rejected Bayer’s Nexavar again.

The cost watchdog has endorsed the use of Iressa (gefitinib) as a first-line treatment option for the 70% or so of patients with advanced non-small cell lung cancer who have epidermal growth factor receptor-tyrosine kinase (EGFR) mutation positive tumours.

AstraZeneca said it is delighted with the news, which it considers a “significant advance for personalised medicine”, particularly as the Institute’s sister body across border, the Scottish Medicines Consortium, closed the door on the drug earlier this month and NICE itself initially said it was minded not to recommend Iressa for NHS use.

According to NICE, its preliminary rejection came from the fact that its Committee was unable to properly evaluate whether Iressa would offer the NHS value for money, as it did not have sufficient data to assess its likely incremental cost compared with standard platinum combination therapy or with Eli Lilly’s Alimta (pemetrexed) and cisplatin.

But now the Institute has published draft guidance recommending the drug’s use after deeming it a cost effective use of NHS resources, taking into account a patient access scheme proposed by AstraZeneca under which Iressa is provided at no cost for patients treated for up to two months and, for all others, at a single fixed cost irrespective of the duration of treatment.

According to Carole Longson, Health Technology Evaluation Centre director at NICE, a number of treatments have already been recommended to treat NSCLC, but Iressa “offers an advantage because it is taken in tablet form, can be taken at home, and would allow patients to carry on with normal daily activities”.

Xeloda in for gastric cancer
Meanwhile, it was also good news for Roche after the cost regulator published draft guidance recommending Xeloda in combination with a platinum-based chemotherapy regimen as a first-line treatment for patients with inoperable advanced stomach cancer.

The current standard of care for patients with inoperable stomach cancer is fluorouracil via an infusion pump. But, as Longson notes, Xeloda-based regimens are not only at least as effective but, as the drug is taken orally, it also offer the important advantage that patients need fewer visits to hospital.

As Xeloda works at least as well as the existing treatment and is more convenient for patients, the Institute’s Appraisal Committee has taken the rare decision “to go straight to a Final Appraisal Determination in order to speed up access to this treatment”, Longson explained, and consequently final guidance is expected in July.

Nexavar appeal fails
On the downside, the NICE is sticking to its guns regarding its previous rejection of Nexavar (sorafenib) to treat patients with liver cancer, after an appeal by Bayer failed to change the cost regulator’s opinion on the drug.

According to Bayer, in rejecting Nexavar the Institute “failed to place adequate weight on innovation and has therefore acted unfairly and not fulfilled its obligations to the Secretary of State in considering the long term benefits of innovation to the NHS”.

The company also argued in its appeal that the Appraisal Committee failed to explain why it changed its conclusions on overall survival following treatment with the drug, and that NICE acted in a “non-transparent and unfair manner” by failing to reveal the degree to which evidence on appropriate survival extrapolation methods was considered.

However, despite the firm’s objections, NICE insists that the drug’s high cost – calculated to be around £52,000 per QALY gained - cannot be justified by its “marginal benefit”.

Normal life expectancy of patients diagnosed with liver cancer is less than 24 months, and while the appraisal committee agreed that trial evidence shows that Nexavar is able extend survival by an average of 2.8 months, the cost of £27,000 per patients is simply too much for the NHS to bear.

The Institute’s chief executive Andrew Dillon expressed disappointment that NICE was unable to recommend the drug’s use, but even taking the proposed patient access scheme into account, under which Bayer offered to pay for every fourth pack, “the price is simply too high to justify using NHS money which could be spent on better value, more effective cancer treatment”.