The National Institute for Health and Care Excellence (NICE) has issued revised draft guidance reversing its decision to restrict access to Roche’s Tarceva (erlotinib) in patients with second-line non-small cell lung cancer (NSCLC).

In 2008, NICE recommended Tarceva for use on the NHS, and since then the treatment has become the standard of care for relapsed NSCLC, with 60% of clinicians choosing to prescribe it over chemotherapy, says Roche.  

However, in February NICE issued an Appraisal Consultation Document (ACD) stating that access to the drug would  be limited following a review of the existing guidance which found that Tarceva no longer met the Institute’s criteria for clinical and cost effectiveness. But following a consultation, NICE has now modified its draft guidance to allow the continued use of Tarceva on the NHS for relapsed NSCLC.

Roche has welcomed the move, saying that it will benefit around 2,000 patients a year. ”The voices of clinicians and patients have been heard,” said the company.

The decision was also applauded by Dr Mick Peake, clinical lead at the National Cancer Intelligence Network (NCIN). “We are glad that NICE is taking clinical and patient opinion into consideration during the drug appraisal process and is ensuring continued access to the standard of care for second-line lung cancer patients,” he said. 

“Lung cancer is one of the most difficult cancers to treat and so it is crucial that we have a wide array of treatment options to choose from. I am therefore extremely relieved that erlotinib will continue to be available through the NHS as a treatment option for patients with relapsed NSCLC,” added Dr Peake, who is consultant physician at the University Hospitals of Leicester NHS Trust.

A key factor in NICE’s change of heart was the side-effect profile of the chemotherapy alternative, docetaxel. This product is associated with some severe side-effects such as life-threatening febrile neutropenia which can be costly to manage, often requiring hospitalisation for antibiotic therapy. In addition, while docetaxel needs to be given intravenously in hospital, erlotinib is taken at home orally, Roche points out.

The new consultation will run until April 29, and NICE is expected to issue its final decision by September.