NICE has issued a positive appraisal for Lynparzatm (olaparib) for the treatment of BRCA-mutated ovarian cancer – the first NICE-approved medicine for ovarian cancer since 2003.
The new treatment will be available to women in England and Wales with platinum-sensitive relapsed (PSR) BRCA-mutated (BRCAm) high-grade serous ovarian cancer who have had 3 or more courses of platinum-based chemotherapy. This is the first time that NHS patients will have access to olaparib despite it receiving European marketing authorisation 12 months ago and being available to patients in a number of other countries in Europe and in the US.
Ovarian cancer causes more than 4,000 women in the UK to die each year, and the UK’s survival rate for the disease lags behind other major European countries with England having the lowest five-year survival rate in Europe. 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. The only other treatment options are chemotherapy or surgery.
Olaparib was not recommended by NICE for women with BRCAm ovarian cancer who have completed 2 courses of chemotherapy because this patient population did not meet the strict End of Life (EoL) criteria used in the assessment process. The average life expectancy for patients in the olaparib study was 26 months, and the NICE EoL cut-off is 24 months or less. It is estimated olaparib will be available to 400 NHS patients in England and Wales, and 50 women who meet the European licensed indication will be denied access.
The approval was based on clinical trial data that shows that olaparib provides an important quality of life benefit by increasing the time it takes for the disease to progress and the time to further chemotherapy cycles. 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.
To date, the most common side effects experienced by patients taking olaparib were mild to moderate – including nausea, fatigue, vomiting and anaemia – but did not cause the patient to stop taking treatment.
Professor Jonathan Ledermann, Professor of Medical Oncology at the University College London Cancer Institute and Primary Investigator of the pivotal olaparib clinical trial, said: “Most women with ovarian cancer who respond initially to treatment will have a recurrence of their cancer and require further courses of chemotherapy. Olaparib is the first personalised treatment for BRCAm ovarian cancer and trials have shown that it significantly extends the interval between relapses; for more than two years in a quarter of all patients on the drug, something not seen before with chemotherapy in women with recurrent ovarian cancer.
“While today’s decision by NICE will be welcomed by all those involved in treating and supporting women with this disease, it is disappointing that the decision has taken so long and some will still not have access."
Lisa Anson, Country President UK and Ireland of AstraZeneca, the pharmaceutical manufacturer of olaparib, said: “AstraZeneca is extremely proud to be launching a new, targeted and much-needed ovarian cancer treatment for women with BRCA-mutated ovarian cancer in England and Wales. We have welcomed the collaborative approach from NICE to achieve this outcome and their willingness to be flexible within a constrained assessment methodology. However, the review process and final decision for olaparib symbolise the urgent need for overall medicines access reform.
“Despite being a global leader in the discovery and development of ground-breaking medicines, the UK has the worst overall cancer outcomes in Western Europe. If this is to improve, we need to reform the medicines value assessment framework, increase investment in the latest medicines and focus more on measuring patient outcomes. AstraZeneca will continue to work collaboratively with Government, the NHS and NICE to make this a reality as soon as possible.”
Olaparib was discovered and developed in the UK. The mode of action is based on Nobel Prize-winning science and offers a new approach to the way ovarian cancer is treated.
The European Commission approved olaparib on 16 December 2014 for the treatment of women with relapsed BRCAm ovarian cancer who have responded to chemotherapy.
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