The National Institute for Health and Clinical Excellence has put out a call to Swiss drugmaker Roche for more data in support of MabThera's use on the National Health Service.
The cost regulator is currently assessing whether MabThera (rituximab, also sold as Rituxan) has a place on the NHS in England and Wales as a first-line maintenance treatment for patients with advanced follicular non-Hodgkin’s lymphoma.
Maintenance therapy is used to prevent cancer recurrence following initial treatment with chemotherapy, and as this has not been available for NHL to date, MabThera could offer NHS patients new hope for delaying further progression of the disease and the need for subsequent chemotherapy.
NICE believes that the drug could well be a valuable (and cost-effective) option for patients particularly as there is currently no maintenance option available at this stage of the disease, but it says that there are uncertainties in survival data that remain unaddressed by the manufacturer, placing a huge question mark over MabThera's future in the health service.
"The evidence has highlighted that [MabThera] could keep a patient’s cancer in remission after they have had chemotherapy but it remains unclear as to exactly how long this effect lasts for and whether this can also improve the survival of patients", said Peter Littlejohns, Clinical and Public Health Director at NICE.
Preliminary guidance by the Institute's Appraisal Committee recommended the drug's use on the NHS in December last year, but alongside a request for additional information on the drug to help determine its cost-effectiveness.
But given that Roche has thus far failed to address these questions adequately, and taking into consideration stakeholder objections during the consultation because of questions over survival and quality of life benefits, the Committee says it is now "minded not to recommend rituximab as a first-line maintenance treatment unless further data is submitted".
The drugmaker has until March 22 to submit further evidence, NICE said.