We respond to NICE provisional decision not to recommend alpelisib with fulvestrant for routine use on the NHS

“It's disappointing that NICE has provisionally been unable to approve alpelisib with fulvestrant for routine use on the NHS as a new important treatment option for certain secondary breast cancer patients.¹

“This would have been the first targeted treatment available for certain patients with a PIK3CA mutation, which is estimated to be found in around 30-40% of oestrogen receptor positive, HER2 negative breast cancer cases.

"By potentially delaying the need for chemotherapy and the debilitating side effects it can bring, this additional treatment option could have brought patients huge relief and precious hope of staying well, for longer.

“While this provisional decision isn’t wholly unexpected at this stage due to certain limitations and uncertainties in the clinical evidence², it’s essential that Novartis and NICE work together to urgently address these concerns.

"And it's essential that they consider any scope to improve the treatment’s cost-effectiveness, so that this provisional decision is reversed.”

ENDS

Notes to Editors

1. Patients with hormone receptor-positive, HER2 negative, PIK3CA mutated locally advanced or secondary breast cancer after hormone treatment, after a CDK 4/6 inhibitor plus aromatase inhibitor.
2. Analysis suggests that alpelisib with fulvestrant may be more effective than the current NHS treatment option - everolimus with exemestane.