Roche is to appeal against the National Institute for Health and Clinical Excellence (NICE)’s decision not to recommend the use of Tarceva (erlotinib) for the treatment of locally-advanced or metastatic non-small-cell lung cancer on the National Health Service (NHS) in England and Wales.

Confirming an earlier ruling, NICE’s Final Appraisal Determination (FAD) on Tarceva last week concluded that the drug “could not be considered a cost-effective use of NHS resources” when compared with either docetaxel or best supportive care. However, it adds that people currently receiving Tarceva “should have the option to continue therapy until they and their clinicians consider it appropriate to stop.” The Appraisal Committee which assessed Tarceva also says it awaits the results of ongoing trials comparing the drug with docetaxel, and recommends further research into subgroups for whom Tarceva “may provide greater benefit.”

Roche says it will be challenging this decision to prevent it from becoming final guidance to the NHS, as this “would potentially deny 2,300 lung cancer patients one of their last hopes of treatment,” and “isolate England, Wales and Northern Ireland as the only countries in western Europe not to fund Tarceva.”

“We used to talk about postcode prescribing - this is passport prescribing,” said John Melville, Roche’s UK pharmaceutical general manager. “It is unusual for Roche to appeal a decision so vociferously but we are convinced, along with a majority of other countries, that Tarceva is cost-effective,” he added.

Roche says the evidence it submitted for the appraisal demonstrates that Tarceva is both clinically and cost-effective. However, NICE has failed to utilize the available evidence base appropriately and "seems to have completely disregarded the evidence of the expert clinical community (lung oncologists)," it claims. “This negative decision clearly demonstrates a disconnect between the Department of Health’s Cancer Reform Strategy, which calls for a world-class cancer service, and the reality inflicted on lung cancer patients by NICE,” the firm adds.

With over 38,000 patients diagnosed each year, lung cancer is the UK’s biggest cancer killer, and their only alternative treatment is an intravenous chemotherapy that can damage the blood and, in some cases, lead to severe and potentially fatal infections, says Roche. Because Tarceva is an oral, targeted chemotherapy, it can be taken at home where there is no risk of hospital-acquired infections, it frees up hospital resources and does not risk the infections often seen with intravenous chemotherapy, which are potentially life-threatening to patients and costly to treat, the firm adds.

Nick Thatcher, professor of medical oncology at the Christie Hospital in Manchester, said he was “particularly disappointed” with the ruling. “NICE has undervalued the benefits to a patient and in doing so, has undermined lung cancer specialists’ ability to do what’s best for those in our care. Denying a treatment with less serious side effects than intravenous chemotherapy, that can be taken at home, is at odds with the Cancer Reform Strategy’s promises to patients,” he said.

Roche has reminded NHS commissioners and trusts, and Primary Care Trusts (PCTs), that the appraisal process has not been concluded and there are no universal restrictions on Tarceva being prescribed within its licensed indication. “Department of Health Good Practice Guidance states that it is not acceptable to cite lack of NICE guidance as a reason for not prescribing a specific treatment,” it adds.

- The guidance on Tarceva was developed using NICE’s Single Technology Appraisal (STA) process. The period for appeal against the FAD will close at 5pm on May 9.