The National Institute for Health and Care Excellence has ruled against expanding use of AstraZeneca/MSD's Lynparza to a wider patient population with ovarian cancer.
The drug’s recent expanded approval in Europe allows its use for maintenance treatment of relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer, that is in response to platinum-based chemotherapy, in adults regardless of BRCA status.
In an appraisal consultation document, the Institute said clinical trials show that while Lynparza (olaparib; pill formulation) extends the time until cancer progresses compared with routine surveillance, it is not cost effective in this setting.
Lynparza is already NICE approved in capsule formulation to treat a narrower range of patients - that is for those who have BRCA1/2 mutations and who have had three or more rounds of platinum-based chemotherapy.
AZ said it now will continue to engage with NICE, NHS England and the Cancer Drugs Fund “with the aim of enabling access to this treatment for ovarian cancer” for the wider patient population.
For one, the firm argues that the drug should be eligible for end-of-life consideration - and thus a £50,000 per QALY threshold as opposed to the standard £30,000 per QALY limit - given that real-world data show that life expectancy in this patient population is less than 24 months.
“NICE’s decision was a complicated one and cost was a major factor,” said Professor Paul Workman, chief executive of The Institute of Cancer Research.
“Use of olaparib in women without BRCA mutations would be more clearly cost-effective if we could learn more about which women benefit and had a better test to pick them out for treatment."
The UK has the worst five-year survival rate for ovarian cancer in Europe. Six out of 10 cases of the disease are diagnosed at an advanced stage.