The draft guidance recommends olaparib (also known as Lynparza, produced by AstraZeneca) used with bevacizumab (also called Avastin, produced by Roche) as an option for people whose cancer has had a complete or partial response after first-line treatment with platinum-based chemotherapy and bevacizumab. The cancer must also test positive for homologous recombination deficiency (HRD).
Taken twice-daily in pill form, olaparib is a type of drug called a poly-ADP-ribose polymerase (PARP) inhibitor. These work by blocking PARP proteins which repair DNA in damaged cancer cells, causing the cells to die.
People without a mutation in the BRCA genes have limited access to PARP inhibitors in the ovarian cancer treatment pathway in England. Currently, only niraparib is available as an option for these patients via the Cancer Drugs Fund after first line platinum-based chemotherapy.
With this new recommendation, patients with HRD would be eligible for the olaparib combination treatment regardless of BRCA status, providing a further treatment option at an earlier stage for people with advanced ovarian cancer. Around 1,100 more women will be eligible for this treatment in England.
Clinical trial evidence suggests that olaparib plus bevacizumab increases the length of time people live before the disease progresses, compared with a placebo plus bevacizumab (37.2 months versus 17.7 months, respectively). However, clinical trial data is unclear on whether the combination treatment increases overall survival.
Due to the lack of data on the overall-survival benefit, the cost effectiveness estimates are uncertain so the treatment cannot be recommended for routine use in the NHS.
The committee recognised that olaparib with bevacizumab has the potential to be cost-effective if found to increase survival, and therefore recommended it for use on the CDF. This will allow more evidence to be collected to address the uncertainties around overall survival.
Meindert Boysen, director of the NICE Centre for Health Technology Evaluation, said: “We recognise how important it is to have treatments that postpone disease progression, as they allow people a better quality of life.
“Olaparib with bevacizumab has shown the potential to improve the lives of hundreds of individuals. We don’t yet know whether the benefits on disease progression translate in longer-term outcomes, and we look forward to seeing what the time spent on the CDF will uncover about its benefits for the future.”
Two changes to current practice will be needed to implement the new recommendation: clinicians will need to introduce testing for HRD and will need to offer bevacizumab alongside platinum-based chemotherapy as a first-line treatment. Clinical experts confirmed it would be possible to implement these changes and the committee took account of the associated costs and consequences in its decision making.
You can find the draft guidance here.
Update: The final guidance has now been published and can be accessed here.