NEW YORK – The UK's National Institute for Health and Care Excellence has published a draft guidance recommending approval of olaparib (AstraZeneca's Lynparza) as a maintenance treatment for patients with BRCA1/2 mutation-positive, advanced high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have responded to first-line platinum chemotherapy.
The government will pay for the twice-a-day tablet via its Cancer Drugs Fund if certain conditions of an access agreement between AstraZeneca, the National Health Service England, and NHS Improvement are met. The resources of the Cancer Drugs Fund are needed to provide access to olaparib in this setting, since the ongoing SOLO-1 trial has shown that the drug delays progression for three years compared to placebo, but has not yet demonstrated an overall survival advantage.
"We are pleased that the company has agreed to a commercial arrangement for olaparib that will allow it to be made available immediately to people who currently have an unmet need for maintenance treatment," Meindert Boysen, director of the NICE Centre for Health Technology Evaluation, said in a statement.
The conditions laid out by NICE restrict the drug to being given to patients until they experience radiological progression or unacceptable toxicity, or for up to two years if there is no evidence of progression. Patients who progress at two years can continue to receive the PARP inhibitor upon the recommendation of their doctors. The list price for olaparib tablets is $5,740.61 (£4,635.00) per 28-day cycle, but the company is providing it to the NHS at an undisclosed discounted rate.
NICE estimated that around 700 patients a year will be eligible to receive olaparib. A final guidance is slated for publication from NICE in August.
The US Food and Drug Administration approved olaparib for this indication, based on the results of the SOLO-1 trial, in December 2018.