NICE recommends interim funding for GSK's Zejula in ovarian cancer

Women with newly-diagnosed advanced ovarian cancer have a new treatment option in England after NICE recommend interim funding for GlaxoSmithKline’s Zejula (niraparib) in final guidance.

Zejula competes with AstraZeneca/Merck & Co’s PARP inhibitor class rival Lynparza (olaparib) but in this case it has an advantage in this maintenance therapy use as it can be used regardless of whether the BRCA mutation is present.

GSK estimates that around 3,000 people could benefit annually from the decision covering advanced high-grade epithelial ovarian cancer, fallopian tube or primary peritoneal cancer, who have completed and shown a response to platinum-based chemotherapy.

The drug will be paid for by the Cancer Drugs Fund, which provides interim funding until further data can be gathered that can help NICE with its cost-effectiveness calculations.

This indication is supported by data from the phase 3 PRIMA study, which enrolled patients with newly diagnosed advanced ovarian cancer following a complete or partial response to platinum-based chemotherapy regardless of biomarker status.

The primary endpoint in PRIMA was progression-free survival (PFS) analysed sequentially first in patients with BRCA-like mutations, then in the overall population.

Results showed Zejula significantly improved PFS regardless of biomarker status – in patients with homologous recombination deficiency (HRd) mutations, Zejula resulted in a 57% reduction in risk of disease progression versus placebo. 

In the overall population there was a 38% reduction in the risk of disease progression or death compared with placebo.

However NICE usually requires overall survival data before making decisions on long-term funding NHS funding.

As a result, the cost-effectiveness body has decided to use the CDF until GSK has the required survival data, it said in the guidance document.

In a managed access agreement with NICE, GSK has agreed an confidential discount to the list price of £4,500 for 56 100mg capsules, excluding VAT.

Poly-(ADP-ribose) polymerase (PARP) inhibitors are targeted therapies that work by exploiting cancer cells’ tendency to use a back-up system to keep control of mutations in their DNA.

By interfering with this process PARP inhibitors cause cancer cells to self-destruct as genetic defects mount, while leaving healthy tissue unaffected.