NICE has today issued Technology Appraisal Guidance (TAG) for olaparib (Lynparza) for the treatment of platinum-sensitive relapsed (PSR) BRCA-mutated (BRCAm) high-grade serous ovarian cancer in women who have had 3 or more courses of platinum-based chemotherapy. In it’s appraisal NICE decalred that olaparib was a cost-effective option.
Following the release of the guidance clinical commissioning groups, NHS England and local authorities are required to comply with this recommendation and ensure that olaparib treatment is funded and accessible within 90 days.
Survival rates for ovarian cancer in the UK are amongst the lowest in Europe. The five year survival rate is currently just 43%, yet if diagnosed at the earliest stage, this figure could rise to 90%.
Ovarian cancer is responsible for more than 4,000 women in the UK to die each year, while up to 21% of women with the most aggressive form of ovarian cancer have the genetic BRCA mutation and it is this patient group for whom olaparib is licensed in Europe. The only other treatment options are chemotherapy or surgery.
NICE has recommended use of olaparib in patients who have completed three or more courses of platinum based chemotherapy and who meet the European license criteria. Olaparib is the first targeted therapy for women with BRCAm ovarian cancer and clinical trials show that it provides an important quality of life benefit by significantly increasing the time it takes for the disease to progress and the time to further chemotherapy cycles.
Trials indicated that there was an 82% risk reduction in time to progression versus standard ‘watch and wait’, which is the largest ever effect for this outcome in women with ovarian cancer (HR 0.18, p<0.0001; median progression free survival, 11.2 months versus 4.3 months). These data are for the overall population that olaparib is licensed for and data for the NICE-approved patient group are consistent with this.
Professor Jonathan Ledermann, Professor of Medical Oncology at the University College London Cancer Institute and Primary Investigator of the pivotal olaparib clinical trial said: “The positive NICE guidance for olaparib represents a turning point for how women with ovarian cancer and a BRCA mutation are treated by the NHS in England. These patients with recurrent ovarian cancer tend to have a poor prognosis and until now their treatment options have been limited to conventional chemotherapy and surgery. I urge NHS England to implement this guidance immediately as there are many patients who are waiting for treatment and who could benefit significantly.”
Greg Rossi, Oncology Business Unit Head at AstraZeneca UK, the company behind olaparib, said: “AstraZeneca is delighted that NHS patients in England will soon have access to the first targeted therapy for ovarian cancer. Olaparib is a product of the British science community and it is only right that patients in this country should have the opportunity to benefit from treatment. We hope that NHS England will issue its commissioning policy as soon as possible to allow funding and rapid patient access to olaparib.”
To date, the most common side-effects experienced by patients taking olaparib were mild to moderate, did not cause the patient to stop taking treatment, and included nausea, fatigue, vomiting and anaemia.
Diagnosis of ovarian cancer can present GPs with a number of problems, not least of all regarding the variety of symptoms, which can be similar to gastrointestinal disease, ovarian cysts or urinary tract infections. Combined with a lack of awareness around symptoms and access to diagnostic tests, more than a third of women are diagnosed with ovarian cancer following an emergency admission.
Now available: an exclusive GM special report on the latest developments in ovarian cancer. Download your free copy today.