Roche set to challenge NICE Tarceva decision
pharmafile | November 25, 2010 | News story | Sales and Marketing | NICE, Roche, Roche UK, Tarceva, erlotinib, lung cancer
NICE has again rejected Roche’s lung cancer drug Tarceva in its second round of draft guidance.
Tarceva (erlotinib) was being assessed as a maintenance treatment for people with non-small-cell lung cancer (NSCLC) who have had first-line treatment and their disease has remained stable.
NICE said Tarceva showed some clinical benefit, and from recent clinical trials Roche estimates that it can potentially extend life by around 3.3 months.
However, the independent appraisal committee did not feel the evidence was “sufficiently robust” to demonstrate this extension to life.
Sir Andrew Dillon, chief executive at NICE, said: “Maintenance treatment is a relatively new concept in lung cancer care.
“We have already recommended [chemotherapy agent] pemetrexed as a treatment under some of these circumstances. However, where pemetrexed was demonstrated to offer a potential additional 5.2 months of life to patients, it is uncertain how much benefit erlotinib can offer as a maintenance treatment.”
Dillon added that NICE was “disappointed” not to have been able to recommend a further treatment option for this cancer, but that there was “considerable uncertainty” about its clinical effectiveness in this setting.
The committee considered that Tarceva versus best supportive care would be greater than £50,000 per QALY gained.
In addition, the committee decided that the drug does not fulfil the criteria for evaluating life extending, end-of-life treatments.
It said that the total population for whom Tarceva was licensed was “not small enough to allow the end-of-life advice to apply” and the potential of the drug to extend life was too uncertain.
Roche reacts to Tarceva guidance
Roche said in a statement that it was “disappointed” by the decision and believes that Tarceva should meet the criteria for end-of-life treatments.
John Melville, Roche UK’s general manager, said: “Other treatments have been approved by NICE which we believe have a higher cost per QALY and this decision only helps to widen the gap between the UK and the rest of Europe in the management of lung cancer.
“We are hoping that NICE will reconsider its decision, which seems to go against the spirit of the ‘end-of-life’ criteria.
“We will challenge this decision, but in the interim period the Department of Health has recognised the need to address issues such as this with the launch of the Cancer Drugs Fund, which enables oncologists to make treatment decisions based on clinical judgment rather than on a medicine’s NICE approval status.”
Roche had agreed a patient access scheme with the Department of Health in which the acquisition cost of Tarceva would be reduced by 14.5% (that is, £1,394.96 for a pack of 30 tablets) but NICE said this still didn’t address the question of the drug’s clinical effectiveness.
Ben Adams
Related Content
Combination treatments: Takeda’s Implementation Framework and the broader landscape
Pharmafile talks to Emma Roffe, Oncology Country Head (UK & Ireland) about the combination treatment …
HUTCHMED completes enrolment in phase 3 trial for lung cancer
HUTCHMED has completed patient enrolment for the SANOVO phase 3 clinical trial, investigating the use …
Graphene-based biosensor to support new lung cancer screening test
HydroGraph, a Canadian producer of ultra-pure graphene, has announced a partnership with Hawkeye Bio and …
