Takeda’s Adcetris has become the first drug to win funding for use on the National Health Service in Wales under a new assessment process for ultra-rare medicines.

Adcetris (brentuximab vedotin) has been endorsed by the All Wales Medicine Strategy Group for restricted use in patients with relapsed or refractory CD30+ Hodgkin lymphoma which has not responded to standard treatments, having been reviewed under a new policy for treatments targeting less than 50,000 patients.

The new process adopts a much wider approach to reviewing medicines, including considering degree of severity of the disease as presently managed, the impact of the medicine, whether it may bridge a gap to a “definitive” therapy, as well as the degree of innovation, the group noted.

The positive decision for Adcetris came on the back of clinical Phase II data showing that 75% of patients with relapsed or refractory HL, post ASCT, achieved the primary endpoint of objective response rate, with 33% achieving a complete remission.

Also, after a median of 32.7 months following first dose, 50% of patients were alive at the time of last follow-up, and the median overall survival was 40.5 months, with an estimated three-year survival rate of 54%.

Results 'impressive'

“Results from real-life clinical practice and clinical trials for brentuximab vedotin are impressive, with efficacy data that is rarely seen with a single-agent therapy together with a very acceptable side effect profile,” noted Eve Gallop-Evans, Consultant in Oncology at Velindre Cancer Centre, Cardiff, welcoming the AWMSG’s recommendation.

Adcetris was also backed by cost regulators in Scotland in 2014. Across the border, an appraisal by the National Institute for Health and Care Excellence is scheduled for later this year.