NICE decides not to approve pembrolizumab for ovarian cancer patients in England
Ovarian Cancer Action are disappointed to learn that the National Institute for Health and Care Excellence (NICE) have decided not to recommend pembrolizumab (Keytruda) for women with ovarian cancer in England.
After a second committee meeting in September to assess further evidence, NICE have confirmed their decision not to approve funding for pembrolizumab in combination with chemotherapy, with or without bevacizumab (Avastin), for women with PD-L1 positive* platinum-resistant ovarian, fallopian tube or primary peritoneal cancer whose disease has returned after one or two previous treatments.
For several years women with recurrent ovarian cancer have seen new immunotherapy medicines transform outcomes for other cancer types, with little progress for their own type of cancer. The KEYNOTE trial changed this: Pembrolizumab is the first immunotherapy to have shown that it can help women with PD-L1 positive platinum-resistant ovarian cancer live longer, making it a potentially life-changing option for women whose disease has stopped responding to chemotherapy.
What is pembrolizumab?
In August this year, NICE issued a draft guidance decision not to recommend the medicine, and asked for further evidence in several areas. Ovarian Cancer Action submitted a response to this draft decision, making sure the patient voice was included in the committee’s final appraisal.
In this final draft guidance, the committee acknowledged the significant quality of life impact that ovarian cancer and its treatment has, and agreed that there is a need for more treatment options for platinum-resistant ovarian cancer. They concluded that pembrolizumab plus paclitaxel, with or without bevacizumab, increases progression-free survival, overall survival and quality of life for people living with platinum-resistant ovarian cancer. However, having reviewed all available evidence they decided that even when taking these things into account, the most likely cost-effectiveness estimate for this drug is considerably higher than the range that NICE considers an acceptable use of NHS resources. This decision doesn’t impact the treatment of anyone currently taking the drug.
This Final Draft Guidance can only be appealed on the basis that NICE failed to act fairly in the process, exceeded its powers, or that the recommendation is unreasonable based on the evidence submitted.
Marie-Claire Platt, Ovarian Cancer Action’s Director of Research and Policy says.“We are deeply disappointed that pembrolizumab will not be made available for women with platinum-resistant ovarian cancer in England. This decision comes as a blow to these women who have limited to no treatment options left. We are calling on NICE and the pharmaceutical MSD to come to an agreement that gives these women a chance to survive their disease.”
Ovarian Cancer Action believes it is vital that women with recurrent ovarian cancer have access to a range of treatment options. While there has been positive news this year with the approval of mirvetuximab soravtansine (Elahere), this drug is only available for a sub-group of patients, meaning many still face a shortage of options if their cancer returns.
We will continue to advocate for improved access to innovative cancer treatments and support efforts to bring new options to patients across the UK.
Outside of England
Access to medicines is decided by different bodies depending on where in the UK you live.
In England, which drugs are available on the NHS is decided by National Institute for Health and Care Excellence (NICE).
In Wales, the medicines guidance produced by NICE is followed, and this is overseen by the All Wales Medicines Strategy Group (AWMSG).
In Northern Ireland, the Department of Health makes decisions, but they often follow NICE.
In Scotland, the Scottish Medicines Consortium (SMC) makes decisions about NHS Scotland and this is not related to NICE decisions.
* PL-D1 (programmed death-ligand 1) is a protein that some cancer cells use to hide from the immune system. Drugs that target this pathway remove this protection which helps the body's immune system find and destroy the cells.
